An Ontario Superior Court Justice has certified a class-action lawsuit against Johnson & Johnson, its Canadian subsidiary, Janssen-Ortho Inc. and the Attorney General of Canada, on behalf of Canadians who took the antireflux drug cisapride (Prepulsid).

Cisapride made headlines in March 2000 when Vanessa Young, 15, of Oakville, Ont. died of a heart arrhythmia after taking the drug to ease bloating related to bulimia. Cisapride was contraindicated for patients with bulimia.

Cisapride was pulled from the North American market a few months later. A coroner's jury ruled in 2001 that Young died of heart arrhythmia caused, at least in part, by cisapride toxicity. The jury made 50-plus recommendations, including mandatory reporting of adverse drug reactions by health care professionals and clear label warnings of contraindications. None of the major recommendations have been implemented.

An estimated 350 000 Canadians took cisapride. Lawyers involved in the case say thousands may have experienced adverse effects. In 2004, Johnson & Johnson agreed to pay up to $90 million to settle US lawsuits involving more than 300 deaths and 16 000 injuries related to cisapride. The company has argued that physicians failed to properly prescribe the drug, especially to children.

The Canadian class action claims the company failed “to adequately warn Canadian physicians and their patients of the risks associated with ingesting [cisapride]” despite knowledge of serious problems, and that there was little scientific evidence the drug even worked.

The lead plaintiff, 69-year-old Aline Boulanger of Timmins, Ont. was prescribed prepulsid in 1995 and suffered chest pains and shortness of breath. She was diagnosed with ventricular tachycardia with prolonged QT interval that was linked to the use of cisapride. She continues to require heart medication.

Since Vanessa Young's death, her father, Terrence Young, has been an outspoken advocate for drug safety reform. He says he hopes the class-action case, which is not expected to begin for a year or more (and only if litigants don't settle out of court), will force changes in how doctors report adverse drug effects and how Health Canada manages drug safety issues.

“The delay in this case should show the federal government that the courts are a totally inadequate way to deal with prescription drug safety,” says Young.

When asked to comment, a spokesperson for Janssen-Ortho Inc. faxed a brief statement to the CMAJ indicating it had served notice of intent to appeal the decision and that the company believes the drug “is a safe and effective medicine when prescribed appropriately.”